Opioid Approval Standards Could Change Under New US FDA Plan
Executive Summary
The Overdose Prevention Framework includes considering whether FDA should require new opioids show superior safety compared to existing products.
You may also be interested in...
US FDA Says Opioid Database Firm With Purdue Pharma Connections Reported No Conflicts
Amid criticism of its contract to evaluate opioid data from the Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) survey programs, the FDA says federal databases lack the necessary information on opioid misuse.
Twilight Of The Opioids? Label Updates, Review Changes May Have Less Impact Than Shrinking Pipeline
Many prescribers don’t read drug labels, meaning they may not see the new warnings and recommendations in the immediate- and extended-release opioid labels, says Brandeis’ Kolodny. Meanwhile, as the Senate advances a bill that would allow comparative review of opioids, they make up a smaller amount of the drug development landscape.
Califf Hires New US FDA Senior Advisor, But Duties Seem Vague
As a senior advisor for chronic disease, Haider Warraich will help shape policy and product development in several areas, but the FDA provided few details on the cardiologist’s new duties.